Wrist Pulse Oximeter

Oximeter

Beijing Choice Electronic Technology Co., Ltd.

The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Wrist Pulse Oximeter.

Pre-market Notification Details

Device IDK172366
510k NumberK172366
Device Name:Wrist Pulse Oximeter
ClassificationOximeter
Applicant Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan Dist Beijing,  CN 100041
ContactLei Chen
CorrespondentLei Chen
Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan Dist Beijing,  CN 100041
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-04
Decision Date2018-03-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.